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**Pharmaceutical Industry**

**Regulatory Affairs Technician / Job Description**

**Company description**:
Hetero Europe is a generic pharmaceutical company, founded in 2010 and based in Barcelona, as a B2B subsidiary of Hetero, a global pharmaceutical company headquartered in Hyderabad, India. We specialize in supplying high-quality generic pharmaceutical products to our European clients, as well as providing IP/Regulatory support, embraced by our comprehensive and continuously growing product portfolio of over 200 products of finished dosage forms of oral solids, liquids, and injectables.

**Industry**: Pharmaceutical

**Position**: Regulatory Affairs Technician

**Experience**: mid-junior level

**Job Function**: Regulatory

**Employment type**: Full-Time

**Location**: Viladecans Business Park - 08840 Viladecans (Barcelona)

**Job description**:
Hetero Europe is looking for a dynamic and experienced Regulatory Affairs professional to support the activities of the team. Incorporation is foreseen in Q3 2023.

**Key responsibilities and accountabilities**:

- Reviewing Marketing Application Authorization (MAA) dossiers and liaising with the RA department at the company Headquarters in India.
- Supporting existing and potential clients with regulatory/technical information on Hetero´s products.
- Preparing and submitting dossiers to Health authorities in EU countries using national and decentralized procedures.
- Contacting European Health Authorities to follow up on submissions.
- Reviewing and submitting response documents to deficiency letters of Health Authorities.
- Managing the national phase of the finalized procedures.
- Ensuring adequate maintenance of the dossiers: PSUR submissions, variations, renewals...
- Keeping up to date with the latest regulatory requirements in the region.
- Performing selected pharmacovigilance activities.
- Providing support for the elaboration of quality agreements and for product release.
- Proposing, elaborating and implementing new standard operation procedures.

**Desired Skills and Expertise**:

- Education to a degree level in Pharmacy or a life science
- At least 2 years’ experience in the Regulatory Affairs Department of a pharmaceutical company, preferably with generic medicinal products.
- Experience with European MA procedures (DCPs) will be valued.
- Experience with procedures in European Non-EU countries and Israel will be valued.
- Experience with Pharmacovigilance and Quality Assurance will be valued.
- Good knowledge of current European regulations on the registration of medicinal products. Knowledge of GMP and Pharmacovigilance is a plus.
- Fluency in English, both written and spoken. Computer skills at user’s level.
- Effective teamwork, excellent communication skills, and good organization skills; a flexible and enthusiastic approach to work, using your knowledge to solve technical issues, a customer-friendly attitude, and the ability to work with demanding time frames.

**What we offer**:

- Contract of Employment: permanent position
- Benefits package: health insurance, ticket restaurant.
- Hybrid work model: One day per week for remote work, and as needed for specific circumstances.
- Flexible schedule.
- Good work atmosphere and interaction within a multicultural team.

If of interest, please submit your CV in English and specify salary expectations and availability to start.

Tipo de puesto: Jornada completa

Salario: 30.000,00€-40.000,00€ al año

Beneficios:

- Ayuda al desarrollo profesional
- Eventos de la empresa
- Flexibilidad horaria
- Jornada intensiva los viernes
- Seguro médico privado
- Ticket restaurante

Horario:

- De lunes a viernes
- Flexibilidad horaria

Preguntas para la solicitud:

- Do you currently hold a valid work permit for Spain?
- Are you capable of commuting to the office in Viladecans, Barcelona, Spain?

Idioma:

- Inglés - Competencia profesional (Obligatorio)

Ubicación del trabajo: Teletrabajo híbrido en 08840 Viladecans